Collecting and Studying Tissue Samples From Patients With HIV-Associated Malignancies
NCT ID: NCT01567722
Last Updated: 2023-03-16
Study Results
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View full resultsBasic Information
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TERMINATED
114 participants
OBSERVATIONAL
2013-01-02
2022-01-14
Brief Summary
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PURPOSE: This research trial studies collecting tissue samples from patients with HIV-related malignancies.
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Detailed Description
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* To obtain high-quality, clinically annotated tissue from patients with human immunodeficiency virus (HIV)-1 malignancy.
* To study clinical, genetic, and immunologic parameters that have prognostic significance and/or are involved in the initiation and progression of HIV-1 malignancies, including complete genomic sequence determination of HIV-associated diffuse large B-cell lymphomas, lung cancer, anal cancer, and cervical cancer.
OUTLINE: This is a multicenter study.
Patients undergo tumor, lymph node, bone marrow, or skin biopsy, and peripheral blood mononuclear cells collection. Samples are submitted to the AIDS Malignancy Consortium (AMC) Biorepository and transferred to the AIDS and Cancer Specimen Resource (ACSR). Samples are then analyzed by the Genome Science Center of British Columbia (GSC-BC) and the HIV+ Tumor Molecular Characterization Project (HTMCP) for full genomic sequencing analysis that may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies by flow cytometry, cytogenetics, and molecular studies. Patients' clinical data, demographics, and treatment given are also collected prospectively in order to record treatment outcome and toxicity.
Patients are followed up at 6 months, 1 year, and 2 years for data-reporting purposes.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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HIV-positive diffuse large B-cell lymphoma cases
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and diffuse large B-cell lymphoma.
DNA analysis
This sample will be used for germline DNA analysis.
RNA analysis
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
gene expression analysis
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
polymorphism analysis
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
biologic sample preservation procedure
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
flow cytometry
Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.
medical chart review
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
HIV-positive lung cancer cases
Tissue collection for genomic sequencing from persons with a diagnosis of HIV and lung cancer.
DNA analysis
This sample will be used for germline DNA analysis.
RNA analysis
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
gene expression analysis
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
polymorphism analysis
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
biologic sample preservation procedure
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
flow cytometry
Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.
medical chart review
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
HIV-positive cervical cancer cases
Tissue specimen collection from HIV positive patients with a diagnosis of cervical cancer
No interventions assigned to this group
Interventions
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DNA analysis
This sample will be used for germline DNA analysis.
RNA analysis
RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
gene expression analysis
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
polymorphism analysis
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
biologic sample preservation procedure
Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
flow cytometry
Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.
medical chart review
Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
Eligibility Criteria
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Inclusion Criteria
* Participants must have a diagnosis of a malignancy or clinical findings suggestive of a possible HIV-associated malignancy of one of three types:
* Diffuse large B-cell lymphoma
* Non-small cell lung malignancy
* The presence of any of the following conditions will exclude a participant from study enrollment:
* Absence of sufficient diagnostic tumor-biopsy tissue material to meet the protocol requirements for baseline specimen submission (minimum specimen size of 10 x 10 x 2 mm); repeat tumor biopsy will not be performed solely to meet the protocol specimen-collection requirements
* Participants whose biopsies, for the purpose of this protocol, show a diagnosis of anal intraepithelial neoplasia or cervical intraepithelial neoplasia
* Prior treatment for the study malignancy (including neo-adjuvants), since treatment can affect the mutational spectra of tumors
* HIV infection based on serologic documentation of HIV infection at any time prior to study entry, as evidenced by positive enzyme-linked immunosorbent assay (ELISA), positive western blot, or any other Food and Drug Administration (FDA)-approved (licensed) HIV test; alternatively, this documentation may include a record that another physician has documented that the patient has HIV based on prior ELISA and western blot, or other approved diagnostic tests
PATIENT CHARACTERISTICS:
* Participants must be willing and able to sign an IRB-approved informed consent document
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Emmes Company, LLC
INDUSTRY
AIDS and Cancer Specimen Resource
OTHER
University of Arkansas
OTHER
AIDS Malignancy Consortium
NETWORK
Responsible Party
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Principal Investigators
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Lee Ratner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Washington University Siteman Cancer Center
Locations
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Moores UCSD Cancer Center
La Jolla, California, United States
UCLA Clinical AIDS Research and Education (CARE) Center
Los Angeles, California, United States
George Washington University
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States
Louisiana State University Public Hospital
New Orleans, Louisiana, United States
Washington University School of Medicine
St Louis, Missouri, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Albert Einstein Cancer Center at Albert Einstein College of Medicine
The Bronx, New York, United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
University of Pennsylvania - Abramson Cancer Center at Pennsylvania Hospital
Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Harborview Madison Clinic
Seattle, Washington, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Clinicaltrials.gov summary of trial
Other Identifiers
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CDR0000729843
Identifier Type: OTHER
Identifier Source: secondary_id
AMC-083
Identifier Type: -
Identifier Source: org_study_id
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